Merck will brand sotatercept as "Winrevair™", and market it factually for pulmonary arterial hypertension, as the first FDA-approved activin signaling inhibitor therapy, representing a new class of treatment by once every three-week injection, one that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying hypertension. That is a significant breakthrough in therapy options, for the biologic injection. Here's the NYSE after-market close presser -- and a bit:
. . .“Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” said Dr. Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay and investigator on the Phase 3 STELLAR study. “Based on the Phase 3 STELLAR trial, adding WINREVAIR to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway. . . .”
Now you know. And significantly, with training, FDA has approved it being self-injected by patients able to do so. So no need to go to the doctor's office, or the hospital. That is a nice pull-through possibility.
Now, in unrelated news. . . the able NY Judge Merchan -- in Tangerine's hush money felony case -- has imposed a prospective gag order -- he's plainly not going to tolerate the nonsense that accompanied Tangerine's libel loss, and his $464 million tax- and bank-fraud loss.
“The uncontested record reflecting [Trump's] prior extrajudicial statements establishes a sufficient risk to the administration of justice. . . . Such inflammatory extrajudicial statements undoubtedly risk impeding the orderly administration of this Court. . . .” Merchan wrote in his order tonight.
The Cheeto-lini™ might just end up in the clink, for 24 hours to cool his heels, on a contempt finding -- the first time he pops off, this time around. Sweet.
नमस्ते
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